VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) +1 more— 510(k) K241583

Substantially Equivalent

Remington Medical, Inc.

FDA 510(k) clearance K241583 for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) +1 more, Substantially Equivalent on 2024-08-30. Applicant: Remington Medical, Inc.. Device class: 2.

Clearance details

Device name as filed
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
Applicant
Remington Medical, Inc.
Product code
Code DPW
Device class
Class 2
Regulation
21 CFR 870.2100
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Alpharetta, GA, US
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